CONSTAN, a new clinical trial with the vaccine RUTI® to shorten the current treatment of tuberculosis

  • The RUTI® vaccine -developed by Archivel Farma- will be administered in the CONSTAN clinical trial, approved by the Spanish Agency of Medicines and Medical Devices (AEMPS), to validate its efficacy in patients with
    pulmonary tuberculosis (TB) as an adjuvant treatment to the antibiotic treatment they receive.
  • Tuberculosis is a respiratory infection that affects 10 million people every year and that, in turn, faces the emergence of new drug resistance. It is the second leading cause of death worldwide for infectious disease after
    COVID-19.
  • CONSTAN aims to validate the efficacy of this treatment in two fronts: on the one hand, to boost natural immunity and, on the other, to reduce bacillary load. Both aim to accelerate healing of patients, reduce treatment
    time, and prevent resistance and contagion.

Barcelona, November 29, 2021. The biotechnology company Archivel Farma has promoted the design and implementation of the Phase IIb clinical study CONSTAN to explore the effectiveness and safety of concomitant administration of RUTI® immunotherapy with standard treatment in patients suffering from pulmonary TB together with Dra. Cristina Vilaplana, head of the Tuberculosis Unit Experimental from the Germans Trias i Pujol Research Institute (IGTP), as a Principal Investigator (PI). The study has been approved by the Spanish Agency of Medicines and Medical Devices (AEMPS), and it is planned to include the first patient (FPFV) in early January 2022.

The clinical trial -led by Archivel Farma– will be conducted in collaboration with the Microbiology Service of the Germans Trias i Pujol Hospital, and aims to recruit 56 patients from eight Catalan Healthcare Centres: Hospital Germans Trias i Pujol, Hospital Universitari Vall d’Hebron, Hospital Clínic de Barcelona, Sociosanitari Serveis Clínics, Hospital de Sant Pau i la Santa Creu, Hospital Moisès Broggi, Hospital Universitari Mútua de Terrassa and Hospital del Mar.

If proven effective, this new therapeutic option could be used as a first therapeutic resource in newly diagnosed pulmonary TB patients, in order to reduce the bacillary load in the lung more quickly than the current standard treatment.

Thus, the objective of the CONSTAN clinical trial is to explore the efficacy of RUTI® for TB indication and evaluate the safety of this dosage regimen for patients. In parallel, the RUTI® vaccine is being administered in two other clinical trials as TB treatment adjuvant in India and Ukraine. The Indian study is within the framework of the European Consortium STriTuVaD funded by the European Commission and the Department of Biotechnology of India, which is part of the Horizon 2020 program.

Hopeful preliminary results
Within the framework of the “XXV International Tuberculosis Conference” recently held in Barcelona (November 16-17, 2021) and organized by the Barcelona Tuberculosis Research Unit Foundation (FUITB), the design of the CONSTAN clinical trial was presented, as well as the first preclinical data to support it.

The results of preclinical studies in animal models have shown that the administration of RUTI® concomitantly with the initiation of antibiotic therapy is beneficial, because after one week of its inoculation a very significant reduction of the bacillary load in the lungs, as well as a decrease in pulmonary pathology is observed. According to Dra. Vilaplana, PI of the study, “these results are very encouraging, since they indicate that the administration of the vaccine can be useful to accelerate the healing of patients. In this sense, in the end it could reduce treatment times (which is currently at least six months) and, at the same time, reduce the chances of contagion of the disease. Based on this evidence and in order to be able to translate these findings into clinical practice as soon as possible, we have designed the CONSTAN study to confirm the efficacy and safety of this combination in patients”.

RUTI® in the context of the treatment of infectious diseases
Worldwide, tuberculosis is the second cause of mortality from infectious disease after COVID-19, and is responsible for the death of 1.5 million people during 2020 and 10 million new patients each year. Currently 25% of the world’s population is infected and 10% could develop the disease at some point in their lives. Resistance to antibiotics used as the first line of tuberculosis treatment has become a serious problem (only 60% of patients are cured) that could improve if the treatments were shorter, which would favour their compliance since that lack of adherence is one of the main causes of resistance generation.

In this context, the RUTI® vaccine could help to eliminate the bacillary load more quickly, accelerating healing and, consequently, reducing the time of antibiotic treatment. This would help to prevent and improve recurrence control, new resistance and the spread of infections.

In addition, the RUTI® is being evaluated for the prevention of COVID19 in a clinical trial in Argentina with 250 volunteers run by the company RUTI Immunotherapeutics. This company acquired the exclusive worldwide rights to use the vaccine for the treatment and prevention of viral infections, and in December 2020, it closed a financing round through the collective investment platform Capital Cell.

 

About ARCHIVEL FARMA
ARCHIVEL FARMA is a biotechnology company founded in 2005 in Barcelona by businessman Jose Martínez Martínez from Caravaca de la Cruz (Murcia), and main investor until 2011. Its activity is focused on the development of the RUTI® vaccine, a biological product devised by the Dr. Pere Joan Cardona -from the Germans Trias i Pujol Research Institute– to treat tuberculosis (especially tuberculosis resistant to antibiotics) and other diseases susceptible to immunomodulatory interventions. The company’s objective is to develop the RUTI® vaccine for different indications up to advanced clinical phases and, thus, be able to license it to other pharmaceutical companies that can bring it to market so that it will be accessible to a greater number of people.

Currently, it has a team of more than 20 professionals and has its own manufacturing plant certified with GMP (Good Manufacturing Practices) for the production and release of sterile and biological research products, their packaging and quality control.

About the spokespersons

Olga Rué. CEO of Archivel Farma S.L., which is a biopharmaceutical company located in Badalona (Barcelona) that develops RUTI®, which is a candidate therapeutic vaccine against tuberculosis and other diseases susceptible to immunomodulatory interventions. Currently, she leads the company’s research and business development strategy.

Dra. Cristina Vilaplana. Principal Investigator of the CONSTAN clinical trial. Physician, specialist in Microbiology and Parasitology, and Head of the Experimental Tuberculosis Unit (UTE) of the Germans Trias i Pujol Research Institute. Member of CIBERES and of the Department of Genetics and Microbiology of the UAB. Coordinator of the SMA-TB project, funded by the H2020 Program of the European Commission. Expert in tuberculosis and in the development and evaluation of tools to manage the disease clinically.

Dr. Pere-Joan Cardona. Head of the Microbiology Service of the Germans Trias i Pujol Hospital-IGTP. Specialist in Microbiology and Parasitology. Member of CIBER in Respiratory Diseases. Researcher in the Experimental Tuberculosis Unit (UTE) and inventor of the RUTI® vaccine and Manremyc®. Currently, medical scientific advisor to Archivel Farma for the clinical development of RUTI®.


For more information:
Maria Reales
HealthcareCommunications
Tel. 00 34 629 44 17 50
maria@mariareales.com